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These documents have been created/adopted by the eSubmission CMB or by the TIGes.

HMA eSubmission Roadmap

  • Draft HMA eSubmission Roadmap (endorsed )NEW This further draft of the eSubmission Roadmap v.1.0 has now been endorsed by the IT Directors Executive Committee on 24 July 14 and will be on the agenda for the next EUTMB for further endorsement. More details on the implementation of the Roadmap will also be published at a later stage by the eSubmission CMB.
  • eSubmission Roadmap (powerpoint presentation) NEW This further draft of the eSubmission Roadmap v.1.0 has now been endorsed by the IT Directors Executive Committee on 24 July 14 and will be on the agenda for the next EUTMB for further endorsement. More details on the implementation of the Roadmap will also be published at a later stage by the eSubmission CMB.

TIGes Harmonised eCTD Guidance

TIGes Harmonised NeeS Guidance

EMA eSubmission Guidance for the Centralised Procedure

  • All EMA guidance documents, both practical and strategic, as well as Statements of Intent relating to eCTD and electronic submissions, can be found on the EMA external website here

Best Archiving Practice

 

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